Ospemifene
Selective Estrogen Receptor Modulators
Sold as Senshio · OSPHENA
- Drug class
- Selective Estrogen Receptor Modulators
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 3
Overview
Ospemifene is an active pharmaceutical ingredient in the Selective Estrogen Receptor Modulators group (G03XC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
| EU European Union | EMA | 1 | November 25, 2024 |
GBUnited Kingdom· MHRA
1 product
Uses
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
How to take
CACanada· Health Canada
1 product
Uses
Osphena (ospemifene tablets) is indicated in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).
1 Pediatrics Pediatrics (≤18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. Osphena is not indicated in children. 2 Geriatrics Geriatrics (≥65 years of age): Of the 2209 Osphena-treated women enrolled in the ten (10) Phase II/III trials of Osphena, >19 percent were 65 years of age or older.
No clinically meaningful differences in safety or effectiveness were observed between these women and younger women less than 65 years of age.
EUEuropean Union· EMA
1 product
Uses
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
How to take
Drug interactions
Known interactions involving Ospemifene. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB509990001 · revised May 15, 2026
- [2]Health Canada (DPD) · 02518112 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/002780 · revised November 25, 2024
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.